# FDA 483 - Beeken Biomedical, LLC - July 08, 2021

Source: https://www.keypedia.com/records/483/beeken-biomedical-llc/76052147-1f2c-4299-96b7-480712139539

> FDA 483 for Beeken Biomedical, LLC on July 08, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Beeken Biomedical, LLC
- Inspection Date: 2021-07-08
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Beeken Biomedical, LLC, a medical device specification developer in Stoughton, MA, was cited for significant deficiencies related to the sterility and quality control of its NuStat and NuStat XR hemostatic wound dressings. The inspection revealed failures in preventing contamination, validating sterilization processes, reviewing design changes, establishing product specifications, and managing nonconforming products. These issues led to multiple sterility failures and the distribution of products exceeding sterilization limits.

## Related Officers

- [Sunita Pandey](https://www.keypedia.com/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)
- [Diane M. Biron](https://www.keypedia.com/people/diane-m-biron/12eb885a-3ae3-449d-907e-36133dbdb194)
- [CSO at FDA](https://www.keypedia.com/people/justine-m-corson/5f6e4477-f060-47f1-9165-a63fd6a36226)

Company: https://www.keypedia.com/companies/beeken-biomedical-llc/fbe77eb1-3471-419c-b825-e92d11fa588e

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94